Ascelia’s lead imaging drug Mangoral is covered by an Orphan Drug Designation in the US, providing 7 to 7.5 years of market exclusivity after its marketing authorization approval, and in EU/EEA, data exclusivity can prevail from up to 10 years after marketing authorization. With the patent application filed today, the protection rights can be further strengthened and extended until year 2040. The opportunity to improve the Mangoral product and extend the protection rights can add significant value to Ascelia’s Mangoral franchise.
Mangoral is the first oral imaging drug being developed for liver MRI. The new patent application covers an improved formulation of Mangoral which among other benefits will be even more patient friendly and convenient than today’s formulation.
"We are very pleased to have established an improved formulation of Mangoral to the benefit of patients in need of a liver MRI procedure. It demonstrates our long-term commitment to provide better imaging solutions for a patient population with poor alternatives today, i.e. patients in need of liver MRI procedure which cannot tolerate current contrast agents on the market due to impaired kidney function. The potential to extend the exclusivity rights of our Mangoral franchise until year 2040 will add significant value and is a result of our successful Life Cycle Management work and our focus on developing novel and better medicinal products for patients in need”, said Magnus Corfitzen, CEO of Ascelia.
“In the short-term, we now look forward to recruiting patients for the Phase III study in the second half of this year with final results to be obtained by the end of 2020 or beginning of 2021”, he continued.
For more information, please contact:
Magnus Corfitzen, CEO
Tel. 46 735 179 110
Mikael Widell, IR & Communications Manager
Tel: +46 703 11 99 60
This information is such information as Ascelia Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 7.50 a.m. CET on 10 June 2019.
About Ascelia Pharma
Ascelia Pharma is an oncology-dedicated orphan drug development company located in Malmö, Sweden. The company’s strategy is to develop drugs, which target unmet medical needs, have an established mode of action and a relatively low development risk. Ascelia Pharma has two drug candidates – Mangoral® and Oncoral – currently under development.
Mangoral is a novel contrast agent for MR-scans and is ready for Phase III clinical studies. Mangoral is developed to improve the visualization of focal liver lesions (liver metastases) in patient with impaired kidneys that cannot tolerate current gadolinium contrast agents on the market. Oncoral is an oral chemotherapy tablet ready for Phase II for the treatment of gastric cancer. Ascelia Pharma is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit www.ascelia.com.